Validating Whole Slide Imaging for Diagnostic Purposes in Pathology: Guideline from the College of American Pathologists Pathology and Laboratory Quality Center

This clinical practice guideline provides recommendations on validation requirements for whole slide imaging (WSI) systems to be used for diagnostic purposes in pathology. Recommendations include those on sample size, revalidation, washout period, documenting the validation process, and pathologist training. Outcomes of interest include correlation between WSI and glass slides with respect to accuracy, concordance, average diagnostic certainty, sensitivity, and specificity, in the context of validation requirements.